Comparison · NCT01633541-sae
Platinum/Docetaxal + AT-101 vs Active Comparator Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Platinum/Docetaxal + AT-101 vs Active Comparator Arm: serious adverse events. Trial comparisons, record NCT01633541-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01633541-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.389 | 0.248 | 0.551 | wilson | |
| Risk in group 2 | 0.278 | 0.125 | 0.509 | wilson | |
| Risk difference, group 1 minus group 2 | 0.111 | -0.159 | 0.334 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.598 | 3.28 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 0.484 | 5.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Platinum/Docetaxal + AT-101 than on Active Comparator Arm | 9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Platinum/Docetaxal + AT-101 | platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.~Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).~(AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.~AT-101: Patients received AT-101 40 mg orally two times a day.~Cisplatin: Cisplatin 100 mg/m2~Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg | 14 | 36 | EG000 |
| Group 2 | Active Comparator Arm | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).~Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.~Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg | 5 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
- NCT number
- NCT01633541
- Phases
- PHASE2
- Conditions
- Laryngeal Cancer
- Interventions
- AT-101, Docetaxel, Cisplatin, Carboplatin
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Results first posted
- 2023-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01633541?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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